Process Development Associate (JP7813)
Thousand Oaks, CA. (Onsite Essential)
Potency and Characterization
2+ years (with likely extensions)
3 Key Consulting is hiring an Process Development Associate
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
This position is responsible for developing, qualifying, and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions. Responsibilities include:
Top Must-Have Skill Sets:
- Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations.
- Providing data to support technical reports for investigations, product and impurity characterization, and regulatory submissions.
- Generating and analyzing analytical data to support: product development investigations, and regulatory submissions.
- May contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation.
- Develops and enhances scientific and technical skills.
- Supporting analytical projects involving method development, qualification, and transfer.
Day to Day Responsibilities:
- Pipetting Skills.
- Binding and/or cell-based assay experience.
- Cell Culturing Experience.
- Cell culture.
- Binding assay execution.
- Cell-based assay execution.
- Master’s degree: 1 years of pharma or biotech industry experience.
- Bachelor’s degree & 3 to 5 years of pharma or biotech industry experience.
- Must have Pipetting ,Binding and/or cell-based assay experience, Cell Culturing Experience.
Employee Value Proposition:
- Experience in cell culture and cell biology techniques for quantitative determination of biological activity of proteins.
- Experience in cell-based bioassay development (method characterization, qualification, validation, technical transfer).
- Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies.
- Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines.
- Detail oriented and excellent documentation skills preferred.
- Experience with automated liquid handling preferred.
- Innovation –supports new ideas and initiatives.
- Client orientation– establishes effective and responsive relationships with all clients.
- Communication and Interpersonal skills – communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams.
Exciting opportunity to work on pipeline projects. Opportunity to work in a bio-assay industry leading lab.
- Jumpy job history.
- Lack of top 3 skills.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.